Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

July 25, 2002

Anthrax Vaccine Manufacturer Battles Suit

Dave Eberhart, NewsMax.com

As the military ramps up its long-stalled next round of inoculations for service members considered in harm’s way of bio-attack, former Connecticut Air National Guard pilots Russ Dingle and Tom Rempfer are pursuing a claim on behalf of the United States against BioPort Corp. of Lansing, Mich., the sole American manufacturer of the anthrax vaccine, alleging the drug manufacturer was responsible for the presentation of false claims to the government. The U.S. District Court for the Western District of Michigan was scheduled Wednesday afternoon to hear oral argument on a motion to dismiss filed by BioPort in U.S. ex rel. Dingle v. BioPort Corporation.

Dingle and Rempfer told NewsMax that the basis for their lawsuit arises from their discovery that the anthrax vaccine sold after 1990 to the U.S. government (principally for the involuntary inoculation of military forces) was manufactured without conformity to the approved limitations established by the Food and Drug Administration when it licensed the controversial vaccine.

The two former military aviators, who resigned rather than submit to the involuntary series of anthrax inoculations, focus in their complaint on official findings of the General Accounting Office’s investigation of BioPort that were made public last year.

The government report that was handed to investigative committees on Capitol Hill included these findings:

• "In the case of the anthrax vaccine, the Michigan facility did not notify FDA of a number of changes made in the manufacturing process in the early 1990s and no specific studies were undertaken to confirm that vaccine quality was not affected.”

• "FDA inspectors did not inspect the Michigan facility’s anthrax production room until 1993. According to FDA, access was not granted because its inspectors had not been vaccinated against anthrax. FDA inspectors were able to perform some aspects of inspection — for example, reviewing records — but not equipment and production.”

• "The inspections that FDA ultimately was able to conduct over time found a number of deficiencies, many of which were not corrected in a timely manner. For example, the deficiencies that FDA identified it its February 1998 inspection fell broadly into two categories: (1) those that, although serious, might affect only one or a limited number of batches that were produced when the deficiency was extant and (2) those of a generic nature that could compromise the safety and efficacy of any batch or all batches.”

Vaccine production was suspended after these findings.

Last month when announcing the return of the vaccination program, a DoD spokesman said: "We have a vaccine that protects against anthrax exposure. The vaccine is safe and effective. The Food and Drug Administration approved the vaccine for use, and the FDA certified the manufacturing facility that produces the vaccine. After a comprehensive independent study, the National Academies of Science’s Institute of Medicine fully endorsed the safety and effectiveness of the vaccine just a few months ago in March.”

But perennial critics of the Department of Defense’s anthrax vaccination program such as Dingle and Rempfer immediately pointed to what they said was a troubling déjà vu of DoD pronouncements regarding the controversial drug.

Rempfer of West Suffield, Conn., told NewsMax that the old wolf was just being trotted out in a new ensemble of sheep’s clothing.

President Bush in the 2002 State of the Union address directed development of a new anthrax vaccine, said Rempfer. And there was good reason for the directive, he explained.

'Is It Ethical?'

"The old anthrax vaccine’s new product label lists up to 175 times greater systemic adverse reaction rates, possible birth defects, and deaths reportedly associated with the vaccine as of January of 2002. Is it ethical to remandate the old vaccine despite these revelations and the president’s directive?”

Rempfer said he questioned the wisdom of once again mandating "this known inadequate and costly vaccine” as a "layer” of defense for soldiers given no choice in the matter – "while outstanding legal and 'Gulf War Illness' issues remain unresolved.” Rempfer’s reference is to unresolved issues includes the issue of the many servicemen and servicewomen who were either court-martialed, administratively punished or lost their careers for refusing to take the vaccine the first time around. Hundreds of highly trained pilots and air crewmen were lost from flight status. Also, the vaccine has been linked to the mysterious "Gulf War Illness” that has plagued many of the veterans of that war.

Dingle and Rempfer were forced to resign from their pilot positions at the Connecticut Air National Guard in 1999 when their concerns as to the safety, efficacy, necessity and legality of the military's AVIP (Anthrax Vaccine Immunization Program) and the vaccine itself were not addressed to their satisfaction.

After their resignations, Dingle and Rempfer testified before the House of Representatives.

July 5, 2002

Army educates forces on anthrax vaccine

by Staff Sgt. Marcia Triggs

When the Department of Defense announced resumption of the anthrax vaccine June 28, the Army was ready to take the lead in educating forces on the vaccine's importance.The Anthrax Vaccine Immunization Program Agency is an Army-led organization in charge of providing all of DoD - including all military services -- with educational tools to increase community knowledge on the anthrax vaccine.

"We're not just saying, roll up your sleeves and get a shot," said Col. Randy Randolph, the AVIP director. "We want them to know that the vaccine is safe and effective protection against all forms of anthrax, including inhalation, which is the most deadly form. It also provides round-the-clock protection against the disease." AVIP's responsibility is to provide accessible information fortroops and civilians to learn more about the vaccine.

"What we're going to do is make sure that the information is in front of as many soldiers, civilians and family members as possible," Randolph said. Individuals who are required to get the six-series shot, and the annual booster, should learn about the vaccine at their local level, said Lt. Col. John Grabenstein, deputy director of AVIP. "On our Web site, www.anthrax.mil, there is a commander's tool kit that gives supervisors an overview of the policy, frequently asked questions and answers and a brochure with our toll free number, 1-877-GET-VACC, and Web address on it," Grabenstein said. The AVIP Web site was redesigned to be more user-friendly, andto also answer the most anticipated questions, Grabenstein said.

However, AVIP's e-mail address and toll-free number can be used if someone needs a customized answer, he said. It's the personal questions that are the most important, he added. Everyone on AVIP's 24-member team is involved in getting troops educated on the vaccine, Randolph said. Not everyone's primary mission is to provide customized responses, but anyone could be asked to do it, he said.

"We care very much about the health and safety of our force and that extends to caring about their families," Randolph said. "We want their families to also know and understand why their spouses are taking the vaccine. We want them to know that we're providing them with an added piece of body armor."

Last summer, there was a shortage of the vaccine, and only individuals in high-threat areas were administered the shots. Supplies of the stockpiled vaccine dwindled when Bioport, the sole manufacturer of the vaccine, failed to win the Food and Drug Administration approval for its renovated facility.

However, the Bioport plant passed the final FDA inspection in January and was licensed to produce more of the vaccine, Randolph said. "Not only has Bioport's anthrax vaccine been FDA approved, it has be documented that the drug is safe and effective in a 200-page report by the National Academy of Sciences Institute of Medicine," Randolph said.

The report said that Bioport's vaccine is "reasonably safe," a term that is used because nothing is perfectly safe, Grabenstein said. Like all adult vaccines, it may cause redness or swelling, but that is a reasonable price to pay to get the protection it gives, he said.

Last fall several U.S. citizens died from the inhalation form of anthrax, because they didn't know that they had been exposed and weren't able to get antibiotics in time, Grabenstein said. Without the biological threat protection that the vaccine provides, an enemy could widely disperse anthrax spores on the battlefield and many troops could die, he said.

Being protected is more important now than ever, the president said. There is still the threat of adversaries using weapons of mass destruction, Randolph said.

When the vaccine was halted last summer, it was done in steps and methodically, which is how it will be restarted, Randolph said. There are people being vaccinated now. However, it's only a small portion of the force, and resumption will be done depending on the threat and mission essential functions, Randolph said.